The U.S. Food and Drug Administration announced it has given the green light to Alllumin to treat severe frostbite in adults and reduce the risk of finger amputation.
F.D.A. press release He said the “active ingredient in Aurumin” is iloprost, which “is a vasodilator (drug that widens blood vessels) and prevents blood clotting.” “Iloprost was originally approved in 2004 for the treatment of pulmonary arterial hypertension,” the FDA said.
“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, director of the Department of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, according to a press release. He is said to be the head of the department.
An FDA press release describes a study investigating the use of iloprost in the treatment of frostbite.
“The effectiveness of iloprost in the treatment of severe frostbite was established primarily in an open-label, controlled trial in which 47 adults with severe frostbite were randomly assigned to receive intravenous aspirin. They received standard treatment and were assigned to one of three treatment groups: 1) Iloprost was administered intravenously (intravenously) for 6 hours daily for up to 8 days; Other unapproved drugs for frostbite were given with iloprost (group 2) or without iloprost (group 3). Efficacy was determined by bone scan obtained 7 days after initial frostbite. and was used to predict the need for amputation of at least one finger or toe,” the FDA said.
“At day 7, bone scan findings predictive of the need for amputation were observed in 0% (0 of 16) of patients receiving iloprost alone (group 1) compared to 19% (0 of 16) of patients in group 2. 15) Group 3 patients. The presence of bone scan abnormalities was significantly lower in the two groups that received iloprost. Most patients “had follow-up information on whether they subsequently underwent amputation of at least one finger or toe. The need for amputation was also consistent with bone scan findings,” the FDA added.
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